Hazard - P - B - T - Risk Exempt
Assessment report for Kovaltry (octocog alfa) 17 December 2015, EMA/CHMP/40124/2016 rev. 1.
"BAY 81-8973/octocog alfa is a recombinant replacement protein of the naturally occurring coagulation factor VIII. It is catabolized during human metabolism and no active molecule is excreted by the patient. In accordance with the guideline CHMP/SWP/4447/00 (1), BAY 81-8973/octocog alfa as a protein is exempted from an environmental risk assessment since proteins are unlikely to result in a significant risk to the environment."
Fass environmental information for Helixate NexGen (octocog alfa) from CSL Behring (downloaded 2019-08-20) and Kogenate Bayer (octocog alfa) from Bayer (downloaded 2019-08-20).
The use of amino acids, proteins and peptides is not expected to have any environmental impact.
According to the European Medicines Agency guideline on environmental risk assessments for pharmaceuticals (EMA/CHMP/SWP/4447/00) vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids proteins, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment.
Author: Health and Medical Care Administration, Region Stockholm